Reports: GDUFA implementation may hit delays

Members of Congress to leave Washington this week, return after elections, as user-fee program awaits vote

NEW YORK — The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.

Bloomberg reported that implementation of the law may be delayed because Congress must first pass legislation authorizing the Food and Drug Administration to collect money from generic drug companies, but the problem is that members of Congress will leave Washington this week, not to return until after the Nov. 6 elections.

The Generic Drug User Fee Amendments, part of the renewal of PDUFA that president Barack Obama signed in July, will collect $299 million per year in user fees from generic drug companies over the next five years starting on Oct. 1. This, drug makers and agency officials hope, will help the FDA reduce a backlog of more than 2,000 generic drug approval applications and ensure faster review of future applications.


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